Surgery or Chemotherapy in Recurrent Ovarian Cancer (SOC 1 Trial)?
NCT ID: NCT01611766
Last Updated: 2021-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
356 participants
INTERVENTIONAL
2012-07-19
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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secondary cytoreductive surgery
SCR followed by chemotherapy
Secondary Cytoreductive Surgery
Complete Cytoreduction
Salvage Chemotherapy
6 cycles of postoperative chemotherapy
Salvage Chemotherapy
platinum-based chemotherapy
Salvage Chemotherapy
6 cycles of postoperative chemotherapy
Interventions
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Secondary Cytoreductive Surgery
Complete Cytoreduction
Salvage Chemotherapy
6 cycles of postoperative chemotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with platinum-sensitive, first relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer (EOC, PPC, FTC), which is defined as those with treatment -free interval of 6 months or more.
* A complete secondary cytoreduction predicting score, iMODEL \[Tian WJ, Ann Surg Oncol 2012,19(2):597-604\]\<=4.7, including FIGO stage (0 or 0.8); residual disease after primary surgery (0 or 1.5); Progression-free interval (0 or 2.4); PS ECOG (0 or 2.4); Ca125 (0 or 1.8); and ascites at recurrence (0 or 3.0). If PI and CO-PI reach consensus that the recurrent tumor detected by PET/CT could be completely resected, the index of CA125 could be scored as 0. (Revised on 09/30/2013)
* Assessed by the experienced surgeons, complete resection of all recurrent disease is possible. If single lesion outside the peritoneal cavity can be resected, MRI/CT or PET/CT scan should be performed to exclude simultaneous intra-abdominal lesions.
* Patients who have given their signed and written informed consent and their consent.
Exclusion Criteria
* Patients for interval-debulking, or for second-look surgery, or palliative surgery planned.
* Impossible to assess the resectability or evaluate the score. Radiological signs suggesting complete resection is impossible.
* More than one prior chemotherapy.
* Second relapse or more
* Patients with second or other malignancies who have been treated by surgery, if the treatment might interfere with the treatment of relapsed ovarian cancer or if major impact on prognosis is expected.
* Progression during chemotherapy or recurrence within 6 months after first-line therapy
* Any contradiction not allowing surgery and/or chemotherapy
1. Accompanied by hypoxia serious chronic obstructive pulmonary disease
2. Uncontrolled hypertension, cerebrovascular accident/ Stroke, myocardial infarct, unstable angina, untreated thrombosis, chronic congestive heart failure, or serious arrhythmia in need of medicine.
3. Severe hepatitis, history of liver disease, nephrotic syndrome, renal insufficiency
4. Active ulcer history, abdominal wall fistula, perforation of gastrointestinal tract, or Intra-abdominal abscess, or simultaneously apply treatment/prevent ulcers therapy.
5. Uncontrolled diabetes
6. Uncontrolled epilepsy need long-term antiepileptic treatment.
* Any medication induced considerable risk of surgery, e.g. estimated bleeding due to oral anticoagulating agents, or bevacizumab.
18 Years
80 Years
FEMALE
No
Sponsors
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Fudan University
OTHER
Zhejiang Cancer Hospital
OTHER
Shanghai Zhongshan Hospital
OTHER
Sun Yat-sen University
OTHER
Shanghai Gynecologic Oncology Group
OTHER_GOV
Responsible Party
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Principal Investigators
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Rongyu Zang, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Gynecologic Oncology Group
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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References
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Jiang R, Feng Y, Chen Y, Cheng X, Shi T, Gao W, Jia H, Jiang S, Guo Y, Huang X, Tu D, Zhang Y, Yang H, Zhang P, Liu J, Zhu J, Zang R; SOC-1 Investigators. Surgery versus no surgery in platinum-sensitive relapsed ovarian cancer: final overall survival analysis of the SOC-1 randomized phase 3 trial. Nat Med. 2024 Aug;30(8):2181-2188. doi: 10.1038/s41591-024-02981-0. Epub 2024 Jun 1.
Shi T, Zhu J, Feng Y, Tu D, Zhang Y, Zhang P, Jia H, Huang X, Cai Y, Yin S, Jiang R, Tian W, Gao W, Liu J, Yang H, Cheng X, Zang R. Secondary cytoreduction followed by chemotherapy versus chemotherapy alone in platinum-sensitive relapsed ovarian cancer (SOC-1): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Apr;22(4):439-449. doi: 10.1016/S1470-2045(21)00006-1. Epub 2021 Mar 8.
Related Links
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Shanghai Gynecologic Oncology Group
Other Identifiers
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SGOG OV2
Identifier Type: OTHER
Identifier Source: secondary_id
SGOG OV 2
Identifier Type: -
Identifier Source: org_study_id
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